Orchard Therapeutics Achieves Landmark FDA Approval for Lenmeldy™, Pioneering Gene Therapy for Early-onset Metachromatic Leukodystrophy

Orchard Therapeutics, now under the stewardship of Kyowa Kirin, announces a historic milestone as the U.S. Food and Drug Administration (FDA) grants approv...

March 19, 2024 | Tuesday | News
Biotech Lobbying Powerhouse BIO Ends Association with WuXi AppTec Amid Security Crackdown

Biotechnology Innovation Organization (BIO), a leading lobbying group in Washington, D.C., announced its decision to sever ties with WuXi AppTec, a Chinese...

March 15, 2024 | Friday | Reports
HHS Takes Decisive Action in Wake of Change Healthcare Cyberattack

  Recognizing the severity of the cyberattack, HHS has been actively engaged in regular discussions with UHG leadership, state partners, and a wide a...

March 07, 2024 | Thursday | News
Biocon Biologics Gains Rights to Launch Stelara® Biosimilar in the US by 2025 Following Janssen Settlement

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced...

March 04, 2024 | Monday | News
Atara Biotherapeutics Secures FDA Nod for Pioneering Lupus Nephritis Treatment

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to d...

March 01, 2024 | Friday | News
FDA-approved generic provides cost-effective option for treating cancer

Fresenius Kabi announced  it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms o...

February 29, 2024 | Thursday | News
FDA Expands Biktarvy® Indication for HIV Treatment

- Biktarvy Now First and Only INSTI-Based Single-Tablet Regimen That is FDA Approved and DHHS Guideline Recommended for People Who are Virologically ...

February 27, 2024 | Tuesday | News
FDA Approves Groundbreaking SIMLANDI as First Interchangeable, High-Concentration Biosimilar to Humira

SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. SIMLANDI is the first biosimil...

February 26, 2024 | Monday | News
Pfizer's VELSIPITY® Receives European Commission Approval

Pfizer Inc. has announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union, marki...

February 20, 2024 | Tuesday | News
Sarepta's ELEVIDYS Supplement Accepted by FDA for Duchenne Treatment Expansion

ChatGPT CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 16, 2024 07:00 AM Eastern Standard Time Sarepta Therapeutics, Inc. (NASDAQ:...

February 19, 2024 | Monday | News
Daiichi Sankyo and AstraZeneca's Datopotamab Deruxtecan BLA Accepted in U.S. for Advanced Nonsquamous NSCLC Treatment

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have announced the acceptance of their Biologics License Application (BLA) for datopotamab...

February 19, 2024 | Monday | News
Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)

  Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved...

February 16, 2024 | Friday | News
FDA Grants Orphan-Drug Designation to Mesoblast's Revascor® for Congenital Heart Disease in Children

Mesoblast's Chief Executive, Silviu Itescu, expressed satisfaction with the FDA's decision: “We are very pleased to have now been granted both Orphan...

February 15, 2024 | Thursday | News
Corvus Pharmaceuticals Receives Orphan Drug Designation for Soquelitinib in T Cell Lymphoma, Advances Towards Phase 3 Clinical Trial

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a distinguished player in the clinical-stage biopharmaceutical arena, has achieved a significant milestone wit...

February 12, 2024 | Monday | News

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